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Postpartum Anemia and Postpartum Depression (PPA PPD)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00782912
First received: October 30, 2008
Last updated: January 3, 2013
Last verified: January 2013
History of Changes

October 30, 2008
January 3, 2013
November 2008
April 2013   (final data collection date for primary outcome measure)
Incidence of postpartum depression [ Time Frame: 0-6 weeks postpartum ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00782912 on ClinicalTrials.gov Archive Site
  • Mean Edinburgh Postnatal Depression Scale results [ Time Frame: 0-6 weeks postpartum ] [ Designated as safety issue: No ]
  • Functional status [ Time Frame: 0-6 weeks postpartum ] [ Designated as safety issue: No ]
  • Lactation success [ Time Frame: 0-6 weeks postpartum ] [ Designated as safety issue: No ]
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Postpartum Anemia and Postpartum Depression
Is Postpartum Anemia an Independent Risk Factor for Development of Postpartum Depression?

Postpartum anemia (PPA) and Postpartum depression (PPD) are common afflictions affecting women after childbirth. Both disorders have a significant impact on women's health and functional status. Despite common symptoms and characteristics, a link between these entities has not been adequately studied. The objective of this study is to determine whether postpartum anemia is an independent risk factor for the development of postpartum depression. This prospective cohort study will include all women delivered by elective term cesarean delivery. Hemoglobin and iron levels will be measured, standardized questionnaires for assessment of PPD, functional status and lactation will be administered before discharge and at 3 & 6 weeks post partum. Hemoglobin levels at each time point will be analyzed for correlation with depressive symptoms, functional status and lactation success.
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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Blood samples
Non-Probability Sample

Women after term elective cesarean section
Postpartum Depression
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women after term elective cesarean section

Exclusion Criteria:

  • age < 16 years, preterm (< 37 weeks) delivery, multiple gestation, symptomatic anemia necessitating blood transfusion, significant fetal anomalies or infant not discharged with mother for other reason, preexisting severe chronic maternal illness, preexisting maternal depression and/or current use of antidepressants, other psychiatric illness (e.g. bipolar disease, schizophrenia) or preexisting hemoglobinopathy
Female
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Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00782912
REB 08-155
No
St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
Not Provided
Principal Investigator: Howard Berger, MD St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP